Institutional Conflicts of Interest Policy

Transcription

1 Policy Number: Version Number: 1.0 Classification: Effective Date: August 2, 2016 Responsible Institutional Official: Vice President of Business and Finance 1.0 INTRODUCTION Saint Louis University values its role as a leader in education and scientific advancement. To be competitive, both financially and intellectually, bridging disciplines and industries is essential to establishing and maintaining this leadership role. The University supports the creative ways in which our faculty foster relationships with fellow academics, the sponsors that support and fund research, and the external entities that work to commercialize innovations and bring therapies to patients. With the many positives that may flow from partnerships with external entities comes the potential for institutional conflicts of interest. Such relationships indicate a collaborative interaction between faculty and external entities where additional institutional attention is needed to safeguard the integrity of faculty and their work. 2.0 PURPOSE Saint Louis University, including its officials, must balance many competing interests. It engages in relationships with a variety of external entities that may lead to financial benefit for the institution in many forms, including gifts, business ventures, royalty payments and equity from licensing intellectual property, as well as sponsored educational and research agreements. Such relationships with external entities are generally part of legitimate educational, research, and business activities, but in some cases may create conflicts of interest. The intent of this Policy is not to prohibit or discourage such relationships, but, as much as possible, to manage them so that they do not compromise, or appear to compromise, the integrity of the University s primary missions, including the safety and integrity of its research, education, clinical care, and business activities. 3.0 PERSONNEL AFFECTED This policy applies to Institutional Officials and their Immediate Family, including the President, the Provost, Vice Presidents, Associate and Assistant Vice Presidents, Deans, Associate and Assistant Deans, Academic and Clinical Department Chairpersons, Division Directors, Office Directors, and other institutional administrators as determined by the University s executive leadership and the ICOI Review Committee. This policy applies to the Frost Campus, the Medical Center and the SLU Madrid Campus. 4.0 DEFINITIONS For purposes of this policy, all capitalized terms are defined as follows: Page 1 of 5

2 External Entity: An organization independent from the University, including but not limited to, sponsors, agencies, commercial entities, for-profit and affiliated philanthropic entities, industry, and/or other companies. Immediate Family: Includes any spouse, dependent children, siblings and any other person(s) residing in the Institutional Official s household. Institutional Conflict of Interest (ICOI): A situation in which the financial or business interests of the University, or the personal financial interests of an Institutional Official acting within his or her authority on behalf of the University, can affect or appear to affect the research, education, clinical, business transactions or other activities of the University. Institutional Conflict of Interest Review Committee ( ICOI Review Committee ): The ICOI Review Committee provides oversight to the disclosure process, identifies apparent institutional conflicts of interest, and manages institutional conflicts when they arise. Institutional Official: The President, the Provost, Vice Presidents, Associate and Assistant Vice Presidents, Deans, Associate and Assistant Deans, Academic and Clinical Department Chairpersons, Division Directors, Office Directors, and other institutional administrators, as determined by the University s executive leadership and the ICOI Review Committee. Management Plan: A formal plan of action designed for the purpose of mitigating the risks associated with an identified ICOI. Disclosable Interests: Personal Interest: Anything of value or potential value from an External Entity in the preceding calendar year, received by an individual Institutional Official or a member of his/her Immediate Family, including but not limited to salary, gifts, royalties, license revenue, consulting fees, honoraria, reimbursements, and other forms of compensation. Significant Personal Interest shall also include any ownership or equity in any company, including stocks, options, warrants, and founders interests, but does not include interests in mutual funds, managed retirement accounts and trusts if the Institutional Official does not directly control the investment decisions. A Significant Personal Interest may also exist in a non-financial relationship where the Institutional Official or a member of his/her Immediate Family, participates as an administrator for an External Entity where they maintain a fiduciary responsibility to act in favor of the External Entity s best interest. The ICOI Committee is authorized to determine appropriate financial thresholds for relationships to qualify as Significant Personal Interests. Organizational Interest: Anything of value or potential value from any External Entity in the preceding fiscal year, received by the University as a whole, including but not limited to gifts, royalties, license revenue, and reimbursements. Significant Organizational Interest shall also include ownership or equity in any company, including stocks, options, warrants, and founders interests. A Significant Organizational Interest may also exist in a nonfinancial relationship where the University participates in the administration of an External Entity where they maintain a fiduciary responsibility to act in favor of the External Entity s Page 2 of 5

3 best interest. The ICOI Committee is authorized to determine appropriate financial thresholds for relationships to qualify as Significant Organizational Interests. Significant Personal Interest/Significant Organizational Interests: Any Personal Interest or Organizational Interest deemed by the ICOI Review Committee as needing further review at the ICOI Review Committee level. Please see guidance documents for additional details. University Activities: Research, education, clinical, business transactions or other activities performed by or on behalf of the University. University Offices: For purposes of this Policy, the offices within the University responsible for reporting Significant Organizational Interests, namely the following: Office of Technology Management; Office of Sponsored Programs; Office of Development; Office of the General Counsel; Office of Business and Finance; Clinical Trials Office; Facilities Management and Office of Treasury and Investment. 5.0 POLICY A Conflict of Interest (COI) may exist at an institutional level (an ICOI) and a formal review will be warranted where the University has a Significant Organizational Interest, or any of its Institutional Officials have a Significant Personal Interest, in an External Entity that itself has a financial interest in research, education, clinical care, or business activities conducted at or under the auspices of the University. 5.1 Disclosure by Institutional Officials and University Offices Institutional Officials shall disclose all Significant Personal Interests to the Office of the Vice President of Business and Finance at least annually, and shall update their reports and/or disclosures within 30 days of new or significant changes in financial interests. University Offices shall disclose potential Significant Organizational Interests to Office of the Vice President of Business and Finance prior to entering an arrangement which would give rise to such interest or as soon as possible thereafter if prior notification was not feasible. 5.2 Identification of an ICOI The Office of the Vice President of Business and Finance will conduct an initial review of the disclosure forms and University Office reports and refer any Significant Personal Interests and Significant Organizational Interest to the ICOI Review Committee. The ICOI Review Committee will review potential conflicts based on information in the disclosure forms and University Office reports for apparent and actual Institutional Conflicts of Interest. The Committee will review the circumstances of each situation and determine if an ICOI exists. If the ICOI Review Committee finds that an ICOI exists, then it shall also determine whether and how the ICOI shall be reduced, managed, or eliminated. 5.3 ICOI Review Committee Membership The committee members shall be appointed by the University s executive leadership/audit Committee of the Board of Trustees/President/University Compliance Office and shall have Page 3 of 5

4 sufficient independence and industry expertise, and seniority for objective and informed decision making. 6.0 RESPONSIBLITIES 6.1 Institutional Official is responsible for ensuring that other Institutional Officials within his/her school, department or division comply with this policy, including timely submission of annual disclosures and ad hoc disclosures. 6.2 Office of the Vice President of Business and Finance is responsible for administering the process of disclosure by Institutional Officials and University Offices and for compiling disclosed information for the purpose of ICOI deliberation by the ICOI Review Committee. The Office of the Vice President of Business and Finance is also responsible for i) obtaining information relevant to enable the ICOI Review Committee to develop a Management Plan; and ii) issuing the Management Plan. The Office of the Vice President of Business and Finance will oversee the establishment of adequate enforcement mechanisms to promote conformance with this Policy, and will maintain records of all ICOI disclosures and all actions taken by the University with respect to each identified ICOI. 6.3 ICOI Review Committee is responsible for i) evaluating potential ICOI based on information submitted within the disclosure forms and the University Office reports; ii) developing, in collaboration with the appropriate Institutional Officials or University Offices, practical, effective and verifiable ICOI Management Plans; iii) reviewing and assisting with the monitoring of Management Plans; and iv) recommending corrective actions and/or sanctions for non-compliance with this Policy. 6.4 Executive Leadership is responsible for interpreting and overseeing implementation of and compliance with this Policy. They are responsible for reviewing and approving the mechanisms adopted by each school/department/division for implementing this Policy. 7.0 PROCEDURES Procedures will be maintained internally by the Office of the Vice President of Business and Finance. 8.0 SANCTIONS Individuals who fail to comply with this policy and associated procedures will be subject to disciplinary actions. Non-compliance may result in a notification of suspected misconduct and/or violation reported to government regulatory agencies. Disciplinary action will be guided by the University s Faculty Manual, Staff Handbook, or student guidelines as appropriate. This Policy does not limit the University s ability to impose greater sanctions or impose immediate action against serious violations. Disciplinary actions appropriate to the severity of the infraction will be carried out as needed. 9.0 CHANGES TO THIS POLICY Changes to this policy may be necessary from time to time. At a minimum, the policy and all other program policies, procedures and guidelines will be reviewed on an annual basis. Page 4 of 5

5 10.0 RELATED POLICIES & REGULATIONS Board of Trustees Conflicts of Interest Policy Financial Conflict of Interest in Research Policy Policy on Medical Center Conflicts of Interest in Patient Care and Service Non-Retaliation Policy Uniform Guidance Title II, Part , Subpart B, Conflict of Interest APPROVAL SIGNATURES This policy was prepared by the University Compliance Office at the direction of the Office of General Counsel. REVISION HISTORY EFFECTIVE DATE VERSION NUMBER MODIFICATION August 2, New Policy Page 5 of 5